Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-27 @ 4:15 PM
Study NCT ID:
NCT01951261
Status:
COMPLETED
Last Update Posted:
2020-10-14
First Post:
2013-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Early Assisted Discharge for COPD Exacerbations With Telemonitoring.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'drapat3@gmail.com', 'phone': '911916859', 'title': 'Dra Patricia Mínguez Clemente', 'organization': 'Hospital Puerta de Hierro'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During home follow-up until 6 months after the discharge.', 'description': 'All adverse events caused the patient to be hospitalized.', 'eventGroups': [{'id': 'EG000', 'title': 'Telemonitoring and Telephone Control', 'description': 'Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.\n\nTelemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 0, 'seriousNumAtRisk': 58, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Home Care', 'description': 'Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 0, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rapid atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'necrotizing pneumonia.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pain secondary to vertebral crushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time Until the First Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telemonitoring and Telephone Control', 'description': 'Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.\n\nTelemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.'}, {'id': 'OG001', 'title': 'Home Care', 'description': 'Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '102'}, {'value': '48', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '120'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The reported p-value was calculated.Statistical analysis of the main variable was performed using the Kaplan-Meier method and log-rank test', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'sample size calculation was made, considering it appropriate to set a limit of non-inferiority with respect to the main variable of 1.2 months (36 days), the study being lower if it will have exacerbation before this period of time, with a follow-up of 6 months, It was required to include a sample of 58 patients per group for a potency of 80% and a significance level of 5%.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Change from stable to exacerbation the first time at 6 month', 'description': 'Time until the first exacerbation is the time that patient is stable before a new exacerbation and meaning a good control of the disease.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module, because in the telemedicine group and the home care group, patients who readmission were not included, nor was the patient in whom the monitor did not work.'}, {'type': 'SECONDARY', 'title': 'SATISFAD 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telemonitoring and Telephone Control', 'description': 'Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.\n\nTelemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.'}, {'id': 'OG001', 'title': 'Home Care', 'description': 'Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '30'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Participants will be followed for the duration home care, an expected average of 7 days', 'description': 'Instrument that evaluates satisfaction with home care services in a self-administered. The score ranges from 0 to 30, with the worst value being zero and the best value being 30.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'State-Trait Anxiety Inventory (STAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telemonitoring and Telephone Control', 'description': 'Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.\n\nTelemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.'}, {'id': 'OG001', 'title': 'Home Care', 'description': 'Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).'}], 'classes': [{'title': 'State', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '26'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '25'}]}]}, {'title': 'Trait', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '26'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '27.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Participants will be followed for the duration of home care, an expected average of 7 days', 'description': 'The structure of the scale resulting from the combination of item polarity dimensions and the original two factors (State and Trait Anxiety).\n\nMinimum value 0, maximum value 120. Lower score indicates higher anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all study participants completed the test, so it does not correspond to the number of the flow chart.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Medication Adherence Assessed Using Morinsky-Green-Levine Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telemonitoring and Telephone Control', 'description': 'Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.\n\nTelemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.'}, {'id': 'OG001', 'title': 'Home Care', 'description': 'Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).'}], 'classes': [{'title': 'Initial', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'At 6 month', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed for the duration of home care up 24 weeks', 'description': "Consists of a series of 4 contrasting questions with answers dichotomous yes / no, reflecting the patient's behavior regarding compliance with medication. They are intended to assess whether the patient adopts correct attitudes regarding treatment for his illness; it is assumed that if attitudes they are incorrect the patient is non-compliant.", 'unitOfMeasure': 'percentage of adherents', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all study participants completed the test, so it does not correspond to the number of the flow chart.'}, {'type': 'SECONDARY', 'title': 'Monitoring Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telemonitoring and Telephone Control', 'description': 'Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.\n\nTelemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.'}, {'id': 'OG001', 'title': 'Home Care', 'description': 'Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.23', 'spread': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Participants will be followed for the duration of home care, an expected average of 7 days', 'description': 'It represents the compliance of the patients with respect to the sending of constants through the telemedicine monitor that should be (following the protocol) at least twice a day. The patient was considered compliant if he sent the constant at least 2 twice a day or non-compliant otherwise.', 'unitOfMeasure': 'sending of constant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In the home care group, patients did not send constants. Data from 55 patients were analyzed (2 readmissions and one patient in which the monitor failed were not included in the analysis)'}, {'type': 'SECONDARY', 'title': 'Number of Home Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telemonitoring and Telephone Control', 'description': 'Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.\n\nTelemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.'}, {'id': 'OG001', 'title': 'Home Care', 'description': 'Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '1', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Participants will be followed for the duration of home care, an expected average of 7 days', 'unitOfMeasure': 'visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'COPD Assessment Test (CAT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telemonitoring and Telephone Control', 'description': 'Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.\n\nTelemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.'}, {'id': 'OG001', 'title': 'Home Care', 'description': 'Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).'}], 'classes': [{'title': 'Initial', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '15'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '21'}]}]}, {'title': 'At first month', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '15'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '11'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Participants will be followed for the duration of home care and up to 4 weeks', 'description': "It's a simple questionnaire for assessing and monitoring COPD. It quantifies chronic obstructive pulmonary disease (COPD) impact in routine practice to aid health status assessment.\n\nIt's self-administered in 2 min. It consists of 8 items that measure aspects of cough, expectoration, chest tightness, dyspnea, domestic activities, self-confidence, sleep and energy. Each section is scored from 0 to 5 and therefore a maximum of 40 points can be obtained; a higher score indicates a greater negative impact of COPD. Significant clinical changes correspond to a variation of 2 points or more.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all study participants completed the test, so it does not correspond to the number of the flow chart.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Telemonitoring and Telephone Control', 'description': 'Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.\n\nTelemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.'}, {'id': 'FG001', 'title': 'Home Care', 'description': 'Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'Discontinued', 'achievements': [{'comment': '2-readmission when was at home\n\n1-monitor failure\n\n1-new home hospitalitation 4-missing\n\n1-death', 'groupId': 'FG000', 'numSubjects': '9'}, {'comment': '2-readmission when was at home\n\n1-new home hospitalitation 3-missing', 'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Telemonitoring and Telephone Control', 'description': 'Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.\n\nTelemonitoring and telephone control: Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.'}, {'id': 'BG001', 'title': 'Home Care', 'description': 'Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (dairy visits).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68', 'spread': '8', 'groupId': 'BG000'}, {'value': '70', 'spread': '8', 'groupId': 'BG001'}, {'value': '69', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Body mass index (BMI) (Mean (Standard Deviation)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.1', 'spread': '4', 'groupId': 'BG000'}, {'value': '26.5', 'spread': '4', 'groupId': 'BG001'}, {'value': '26.8', 'spread': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-02-01', 'size': 79727, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-01T10:58', 'hasProtocol': True}, {'date': '2012-02-01', 'size': 66761, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-08-01T10:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-19', 'studyFirstSubmitDate': '2013-09-03', 'resultsFirstSubmitDate': '2020-06-13', 'studyFirstSubmitQcDate': '2013-09-23', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-19', 'studyFirstPostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time Until the First Exacerbation', 'timeFrame': 'Change from stable to exacerbation the first time at 6 month', 'description': 'Time until the first exacerbation is the time that patient is stable before a new exacerbation and meaning a good control of the disease.'}], 'secondaryOutcomes': [{'measure': 'SATISFAD 10', 'timeFrame': 'Participants will be followed for the duration home care, an expected average of 7 days', 'description': 'Instrument that evaluates satisfaction with home care services in a self-administered. The score ranges from 0 to 30, with the worst value being zero and the best value being 30.'}, {'measure': 'State-Trait Anxiety Inventory (STAI)', 'timeFrame': 'Participants will be followed for the duration of home care, an expected average of 7 days', 'description': 'The structure of the scale resulting from the combination of item polarity dimensions and the original two factors (State and Trait Anxiety).\n\nMinimum value 0, maximum value 120. Lower score indicates higher anxiety.'}, {'measure': 'Percentage of Participants With Medication Adherence Assessed Using Morinsky-Green-Levine Test', 'timeFrame': 'Participants will be followed for the duration of home care up 24 weeks', 'description': "Consists of a series of 4 contrasting questions with answers dichotomous yes / no, reflecting the patient's behavior regarding compliance with medication. They are intended to assess whether the patient adopts correct attitudes regarding treatment for his illness; it is assumed that if attitudes they are incorrect the patient is non-compliant."}, {'measure': 'Monitoring Compliance', 'timeFrame': 'Participants will be followed for the duration of home care, an expected average of 7 days', 'description': 'It represents the compliance of the patients with respect to the sending of constants through the telemedicine monitor that should be (following the protocol) at least twice a day. The patient was considered compliant if he sent the constant at least 2 twice a day or non-compliant otherwise.'}, {'measure': 'Number of Home Visits', 'timeFrame': 'Participants will be followed for the duration of home care, an expected average of 7 days'}, {'measure': 'COPD Assessment Test (CAT)', 'timeFrame': 'Participants will be followed for the duration of home care and up to 4 weeks', 'description': "It's a simple questionnaire for assessing and monitoring COPD. It quantifies chronic obstructive pulmonary disease (COPD) impact in routine practice to aid health status assessment.\n\nIt's self-administered in 2 min. It consists of 8 items that measure aspects of cough, expectoration, chest tightness, dyspnea, domestic activities, self-confidence, sleep and energy. Each section is scored from 0 to 5 and therefore a maximum of 40 points can be obtained; a higher score indicates a greater negative impact of COPD. Significant clinical changes correspond to a variation of 2 points or more."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Telemonitoring', 'COPD', 'Home care'], 'conditions': ['COPD Exacerbation']}, 'descriptionModule': {'briefSummary': 'To determine if an early assisted discharge program for acute exacerbations of COPD (AECOPD), with telemonitoring and telephone control, is equally effective and more efficient in terms of use of health care resources, that a home care provided by hospital respiratory nurses and pulmonologists.', 'detailedDescription': 'This study seeks to improve the health of patients with AECOPD by home care after discharge from the Hospital using the technology of the information and the communication. The investigators want evaluate the efficiency, satisfaction (patients, keepers) and effectiveness of a program of early discharge with home care in patients with AECOPD with telemonitoring and telephone control, in relation to the traditional protocol of home care based on nurse and pulmonologist visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the hospital with COPD exacerbation\n* No concomitant serious unstable diseases\n* Without fever in 48 hours\n* Aerosol treatment at the most every 6 hours\n* Treatment with glucocorticoid intravenous \\< 40 mg twice a day\n* A thoracic radiograph without new disease\n* Subjective improvement of the patient\n* Familiar suitable environment\n\nExclusion Criteria:\n\n* Neoplasias and other chronic diseases in terminal situation\n* Alcoholism\n* Intravenous medication\n* Disability to understand and take part in the program\n* Admitted to intensive care unit (ICU) or non invasive mechanical ventilation during the exacerbation\n* Unstability hemodynamic\n* To be an institutionalized patient.'}, 'identificationModule': {'nctId': 'NCT01951261', 'briefTitle': 'Early Assisted Discharge for COPD Exacerbations With Telemonitoring.', 'organization': {'class': 'OTHER', 'fullName': 'Puerta de Hierro University Hospital'}, 'officialTitle': 'Early Assisted Discharge With Generic Community Nursing and Pulmonary Physicians vs Telemonitoring at Home for Chronic Obstructive Pulmonary Disease Exacerbations', 'orgStudyIdInfo': {'id': 'TELEMEDCOPD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'telemonitoring and telephone control', 'description': 'Early discharge from hospital with telemonitoring, telephone control and three nurse scheduled visits.', 'interventionNames': ['Procedure: Telemonitoring and telephone control']}, {'type': 'NO_INTERVENTION', 'label': 'home care', 'description': 'Early discharge from hospital with home care provided by hospital respiratory nurses and pulmonologists (daily visits).'}], 'interventions': [{'name': 'Telemonitoring and telephone control', 'type': 'PROCEDURE', 'description': 'Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.', 'armGroupLabels': ['telemonitoring and telephone control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28222', 'city': 'Majadahonda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Universitary Hospital Puerta de Hierro.', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}], 'overallOfficials': [{'name': 'Antolín Lopez Viña, physician', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Puerta de Hierro'}, {'name': 'Antolín Lopez Viña, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Puerta de Hierro'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Immediately following publication. No end date.', 'ipdSharing': 'YES', 'description': 'Share All of the individual participant data collected during the trial, after identification.', 'accessCriteria': 'Proposals should be directed to drapat1@yahoo.es. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. López Viña', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Dr. López Viña', 'investigatorAffiliation': 'Puerta de Hierro University Hospital'}}}}